Latest Drugwonks' Blog
In July 2013, the Oncology Nursing Society (ONS) held its annual Leadership Weekend. Each year, the organization collects information about oncology nurses, their interests, and their needs. This year, they asked about their membership’s experiences helping patients manage adherence to oral therapies and about their interest in non-CNE training on the topic. The results of the survey, completed by 127 nurses, show that:
• Oncology nurses are experiencing patient non-adherence to oral therapies
• Oncology nurses want and need specific clinical practice assistance to help improve adherence
• Oncology nurses want and will attend educational programs on adherence to oral therapies.
Some findings of interest and importance:
Most Nurses Observe Problems with Adherence
There is evidence that most nurses are observing problems with adherence. Forty-one respondents (32%) said that 25%–50% of their patients have trouble, and another 26 (20%) said that 51%–75% of their patients do. In other words, more than half the respondents said that at least 25% of their patients do not adhere properly to their regimens.
Nurses Highlight Most Common Barriers to Adherence
The nurses ranked various potential causes of non-adherence by their importance to their patients. Cost was viewed as very important by 73 (57%) and important by 31 (24%). Thus, of the 127 total respondents, 104 find that cost, including reimbursement issues and high copays, is a significant barrier to adherence to oral therapies.
Another barrier appears to be side-effect management. Fifty-nine percent said this is an important problem (45 [35%]) or very important (31 [24%]). Cognitive difficulties following instructions are another potential barrier, but perhaps less significant. Although forty-eight (38%) ranked cognitive difficulties as 3 on a 1-5 scale, or of modest importance, another 51 (40%) viewed cognitive difficulties as important or very important in interfering with adherence to oral therapies. Difficulty swallowing seemed to be the least significant barrier, with 55 (43%) suggesting that it was not important or of minimal importance. Twenty-eight (22%) said it was mildly important, and 41 said it was important or very important. Thus, although most of the nurses did not view swallowing difficulty as a critical barrier, it does affect a fair number of patients.
What Do Nurses Need to Help Manage Adherence?
The participating nurses were offered a number of options for possible practical tools or specific aid. They are listed below in order of popularity with the respondents.
• Co-pay and reimbursement assistance was the most positively received form of help with adherence to oral therapies. Here, 119 (94%) of the respondents said they would find the help useful or very useful (70%).
• Side-effect management guides/tear sheets were seen as useful or very useful by another 116 nurses (91%).
• Patient journals/calendars were seen to be useful or very useful by 103 (81%) of the respondents.
• Online resources for both nurses and patients were very positively received, with 100 (79%) respondents viewing them as useful or very useful.
• Patient refrigerator magnets with significant information were also popular, with 72 (57%) indicating they would be useful or very useful.
• Telephone or email follow-up services by drug company or pharmacy were viewed as useful or very useful by 73 nurses (58%).
• Tablet or smartphone apps might be an emerging area of opportunity for drug companies or pharmacies. Fifty-seven (45%) thought they would be useful or very useful.
It’s interesting that the current outreach efforts by pharmaceutical companies and pharmacies rank only one percentage point higher than refrigerator magnets. They’re both 20th century technologies.
What’s also important is that the research differentiated between “online resources” and apps. While both are 21st century technologies, “online” is the substrate -- apps are the wave of the present.
Apps remind, cajole, educate, praise, incentivize, and assist patients in their quest for better health. Apps are at the nexus of safe use, treatment outcomes, and patient satisfaction. And it’s not science fiction.
At present, there are some 17,828 healthcare and fitness apps and 14,558 that can be deemed “medical.” While some are better than others, these numbers tell us one thing – this is not a fad or a trend. It is reality.
I have been working with the Mobile Health Library to help develop their safe use and outcomes support platform. It’s delivered as an app (viable on all tablet and smart phone systems) specifically to address many of the issues called out specifically by the ONS study – facilitating co-pay cards, patient diary functionality, side-effect management, direct physician office communications (via phone, e-mail, and text) and, perhaps most importantly, providing educational services via app-enabled printed materials, website links, and video).
Will our socio-economic “technology gap” lead to a more pronounced “adherence/compliance gap?” It’s an important question. That’s why it’s crucial we remember there is no one-size-fits all solution. But that mustn’t mean we disregard the reality of the growth and pervasiveness of apps, mobile apps. Let’s face it, when it comes to mobile phones, any gap is rather narrow – and it’s getting narrower all the time, literally every day.
The ONS research refers to apps as an “emerging opportunity.” And that’s true. But maybe a better way to phrase it is as an “emergent opportunity.”
Apps are here now. People are using them – more every day, and that includes healthcare providers, patients, and care-givers.
And as Philip K. Dick wrote, “Reality is that which, when you stop believing in it, doesn’t go away.”
The only thing that dies harder than a bad idea is a bad idea with political resonance.
The Wall Street Journal reports:
AUGUSTA, Maine—The hunt for cheaper prescription drugs long has led consumers to reach beyond U.S. borders, but under a Maine law set to take effect Wednesday, their search now will have the state's blessing.
The law, the first of its kind, sanctions the direct purchase of mail-order drugs from some foreign pharmacies. It has ignited a court battle with the pharmaceutical industry and set the stage for a broader fight over access to less-costly medication.
Vendor of choice – CanaRx.
This is particularly appalling since the drugs being sent to U.S. customers from CanaRX are most certainly not “the same drugs Canadians get.” That bit of rhetoric is just plain wrong. CanaRX – by their own admission – sources their drugs from the European Union. And while they may say their drugs come from the United Kingdom, let’s not conveniently forget that 20% of all the medicines sold in the UK are parallel imported from other nations in the EU – like Spain, Greece, Portugal, and Lithuania.
PS/ The drugs CanaRX sells to Americans aren’t even legal for sale in Canada.
Once again -- a brief primer on why drug importation is a bad idea
(1) It doesn’t save money.
(2) The drugs being sent to U.S. customers from Canadian Internet pharmacies are not “the same drugs Canadians get.”
(3) The state experience has been dismal and politically embarrassing.
(4) National Security concerns.
Let’s look at each of these four items.
(1) It won’t save any money. Let’s not forget the non-partisan CBO study that showed that such policy would reduce our nation’s spending on prescription medicines a whopping 0.1% -- and that’s not including the millions of dollars the FDA would need to set up a monitoring system.
(2) The drugs being sent to U.S. customers from Canadian internet pharmacies are not “the same drugs Canadians get.” That bit of rhetoric is just plain wrong. In fact, drugs sold to Americans by Canadian Internet pharmacies aren’t even legal for sale in Canada. This isn’t about the quality of Canadian drug regulation. Canadian Internet pharmacies – by their own admission – are sourcing the drugs they're sending to the United States from outside of Canada. And while they may say their drugs come from Great Britain, let’s not conveniently forget that 20% of all the medicines sold in the UK are parallel imported from other nations in the EU – like Spain, Greece, Portugal, and Lithuania.
And the important political point here is that when Americans are asked if they want drugs from nations other than Canada – the answer is a resounding “no thank you.”
(3) The state experience has been dismal and politically embarrassing. Remember Illinois’ high profile “I-Save-RX”program? Over 19 months of operation, a grand total of 3,689 Illinois residents used the program -- which equals approximately .02% of the population.
And what of Minnesota’s RxConnect program? According to its latest statistics, Minnesota RxConnect fills about 138 prescriptions a month. That's for the whole state. Minnesota population: 5,167,101.
That's not a surprise considering that Minnesota, state officials observed Canadian Internet pharmacies engaging in dangerous practices.
One pharmacy had its pharmacists check 100 new prescriptions or 300 refill prescriptions per hour, a volume so high that there is no way to assure safety.
One pharmacy failed to label its products and several others failed to send any patient drug information to patients receiving prescription drugs.
Drugs requiring refrigeration were being shipped un-refrigerated with no evidence that the products would remain stable.
One pharmacy had no policy in place for drug recalls. Representatives of the pharmacy allegedly said that the patient could contact the pharmacy about a recall "if they wished."
The FDA launched an investigation, confiscating thousands of drug shipments headed for the United States. Some of them were headed for Minnesotans who ordered them over the state's Web site.
When opened, nearly half claimed to be of Canadian origin, but "85 percent of them were from 27 other countries including Iran, Ecuador and China." And 30 of them were counterfeit.
One Minnesota resident discovered that one of his "Canadian" drugs came from Greece, and another came from Vanuatu, a small island in the South Pacific. "I never heard of the place," he said.
Wisconsin also has an importation program, modeled on the one in Minnesota. It too hawks its promise and hides its dangers. All of the legalese buries the fact that the state doesn't accept any responsibility for the safety or effectiveness of any medicines bought on the state's Web site.
The state won't even guarantee that the drugs ordered are what the customer will receive. Not only that, but the state also says that it will not accept any legal responsibility or liability should any of the drugs cause a problem.
And remember Springfield, MA and “the New Boston Tea Party?” Well the city of Springfield is now out of the drugs from Canada business.
(4) National Security concerns. According to a report from the federal Joint Terrorism Task Force, a global terrorist ring with ties to Hezbollah, is importing counterfeit drugs into America by way of Canada. They are doing so for profit today - but could just as easily do so for more nefarious and deadly purposes. And legalizing importation would only facilitate such actions.
And then there are those politically pesky safety issues.
Adding fuel to the reality is a new by the European Alliance for Access to Safe Medicines. The title says it all, “The Counterfeiting Superhighway.”
The report reveals the scope of the unregulated trade of fake pharmaceuticals. Through extensive research and examination of over 100 online pharmacies and over 30 commonly purchased prescription-only medicines, the report makes one thing very clear – we’re not winning the battle.
Key findings from this report
* 62% of medicines purchased online are fake or substandard (including medicines indicated to treat serious conditions such as cardiovascular and respiratory disease, neurological disorders, and mental health conditions).
* 95.6% of online pharmacies researched are operating illegally.
* 94% of websites do not have a named, verifiable pharmacist.
* Over 90% of websites supply prescription-only medicines without a prescription.
* 78.8 of websites violate intellectual property.
My favorite anecdote is the report’s example of an Internet pharmacy whose products came wrapped in pages from the Mumbai Daily News. The most frightening fact, though, is most of the fake medicines “were delivered in seemingly authentic boxes, accompanied by patient information leaflets in good condition and ostensibly trustworthy blister packs.”
"Those who cannot learn from history are doomed to repeat it."
Another way the Republic of South Africa is trying to reinvent itself is in the way it regulates and reimburses for medicines. “BE” means not only “Black Empowerment” (in the post-apartheid sense) but also “bioequivalence.”
I’ve just returned from the “New Developments in Drug Regulation” conference in Pretoria, and there was a lot of serious discussion as to how government regulators can do a better job in a uniquely South African situation.
Some memorable moments …
Tomas Salmonson (Chair of the EMA’s CHMP) told the audience that, while he is a strong believer in transparency, he is not in favor of patient representatives on decision panels. Such representation, he said, “would be like having an elected parliament and then additional members.” He also does not believe that these meetings (akin in many ways to an FDA advisory committee meeting) should be open to the public. I pointed out that having patient reps and open adcomm meetings was a crucial part of the FDA process. Salmonson commented, “I know.”
Transparency translates in different ways. Salmonson noted that one way the EMA promulgates transparency is through its EPARS (European Public Assessment Reports System). The European Medicines Agency publishes an EPAR for every medicine granted a central marketing authorization by the European Commission. EPARs are full scientific assessment reports of medicines authorized at a European Union level.
Salmonson also made the point that a transparent process behind benefit/risk allows consumers and healthcare providers to trust the regulator. FDA – attention must be paid.
Peter Bachmann, head of the Germany’s BfArM (Federal Institute for Drugs and Medical Devices) Coordination Group Unit, spoke to the EMA’s philosophy of being “united in diversity” (a theme that certainly resonated in Pretoria). He also discussed the EMA’s program of mutual recognition, detailing the agency’s methodology of “work-sharing” – a process of cross-national regulatory peer review that should be studied by FDA policy panjandrums for many reasons, not the least of which is quality control.
Ngokoana Khomo, Vice Chair of South Africa’s MCC (Medicines Control Council – the South African version of the FDA) honestly spoke of the tension between “the policy and the practice” of medicines regulation in South Africa. Unspoken was the obvious under-current of a third “p” – politics. And perhaps a fourth – “Potemkin Regulation.” She spoke of the MCC’s mission as “access, equity, efficiency, quality, and sustainability.” Dr. Khomo wisely said that “transparency takes away all suspicions.” But saying and doing is not always the same thing. She also spoke about the rational use of medicine. After all, you can’t spell Ngokoana without NGO.
Ekkehard Baader (Senior Director, Head of EU Regulatory Affairs at Teva) addressed the importance of (and distinctions between) consultation, communications, and cooperation.
Speaking of Teva – there was no discussion of generic drugs during the conference. Not a single mention of API sourcing and quality, not a word about excipients. Disturbing considering the venue and the reality.
BfArM’s Birka Lehmann (a member of PDCO, the EMA’s Paediatric Committee) spoke about issues surrounding informed consent for children (“What if the baby is crying?”) as well as the need for a Paediatric Investigation Plan (PIP) at end of phase 1. Clearly an area ripe for FDA harmonization conversations. Clearly the pediatric train is moving – but EMA and FDA should be on the same track.
At this point you may be wondering what any of this has to do with regulatory reform in the Republic of South Africa. That question was also on the minds of many in the audience who asked questions like, “how much does all of this cost?” and “how many people do you need?” and “how do you train staff?”
Day 2 began with a focus on biosimilars and the successes and failures of the EMA experience – as well as a nod to the work being done by the WHO.
The presentation by Chris Holloway (Group Director of Regulatory Affairs & Chief Scientific Officer at the ERA Consulting Group) was the first person to use the word “quality” – and “process.” He spoke about “balancing needs against expectations.” And it was a welcome addition to the conversation. A breath of real-world reality vs. regulatory theory.
Elwyn Griffiths (WHO) likened his organization’s attempts to develop criteria for biosimilars to the League of Nations – but in a good way.
Haile Selassie, call your office.
Max Wegner (VP, Head of Global Regulatory Affairs, General Medicine at Bayer AG) addressed the unintended consequences of the EMA’s PRAC (Pharmacovigilance Risk Assessment Committee), specifically the impact of public reports of adverse events that had yet to be investigated. I added that the FDA had similar issues with Early Safety Signal Communications and the resultant unintended (but not entirely unsurprising) over reaction by the media and the ensuing leap in non-adherence.
Finally, Marc Blockman of the host Medicines Control Council (MCC) spoke on the issues surrounding both the importance of and difficulties with pharmacoviginance in South Africa. Two of his comments stand out: “Pharmacovigilance is a public service” Bravo. And, “Yes, we have a yellow card – but the form is as much the problem as it is the process.” Sounds familiar.
The conference was, as Pierre Abélard might have put it, a “sic et non” experience. Lots of good advice – but not a lot of applicable next steps. What makes this all the more urgent is the South African position on medicines reimbursement and intellectual property – which shares many philosophical underpinnings with that other bastion of IP protection – India.
Just as there are issues relative to South Africa’s need for regulatory capacity building, so too is capacity building and investment important for the future of intellectual property issues. One frightening passage in South Africa’s proposal states, “The Draft Policy proposes adopting strict patenting rules to “exclude diagnostic, therapeutic and surgical methods from patentability, including new uses of known products, as is the case under the TRIPS Agreement.” Not a good start for a nation that wants to be the “s” added to BRICS.
Further, South African law currently provides no regulatory data protection and the Draft Policy does not include any. Moreover, it explicitly rejects the utility of “blanket data protection” for innovator data and emphasizes the importance of “access to knowledge.” Uh oh. And, of course, there’s a magic rain dance call for compulsory licensing.
The Draft Policy encourages the use of parallel importation to improve access to medicines. Been there. Done that. A clear and present risk to patients.
And these are only a few examples. It gets worse.
The policy disconnect is profound. In April, South Africa sent a sizable delegation to the mega BIO convention with the message that they were “open for business,” and aspires to be a player in global life sciences.
At the same time, local generics manufacturers and the usual suspect activists are whipping up frenzy over intellectual property issues. The same old song. And a dangerous one considering that Scientific American ranks South Africa in the bottom 20% of its life science/innovation index.
(PS/ Under the current regulatory regime, it takes the MCC between 3-5 years after EMA or FDA approval t bring innovative therapeutics to South African patients – the slowest among “advanced” MEA nations. What’s wrong with this picture?)
Rather than looking to emulate the EMA, perhaps South Africa should adopt a reference basket of maybe five to six countries. A good model is Singapore. Everyone’s favorite city-state reviews seven countries—USA, Canada, Australia, NZ, Japan, Switzerland and the EMA. If any two of the seven have approved, then approval is basically a formality.
Talk is cheap.
There is nothing like returning to a place that remains unchanged to find the ways in which you yourself have altered. – Nelson Mandela
At CMPI’s recent Capital Hill conference ,Personalized Medicine and Responsible Access to Pain Medication, Dr. Charles Inturrisi, professor of pharmacology at the Weill Cornell Medical College, laid down the gauntlet:
I want to make a distinction that really does make a difference. And this is the distinction between efficacy and effectiveness. We know that opioids can provide analgesia for some chronic pain patients. We don’t know what percentage but we know that some, and you’ve heard from them this morning, at least one of them. But we also know the treatment outcomes with opioids are variable and not predictable. And this is the take home message if you have to leave. At present, there are no well-validated means of identifying optimal candidates for effective long-term chronic opioid therapy. That’s the problem. That’s the gap in our knowledge. That’s the gap in our evidence base.
We need to learn who will experience good analgesic effectiveness at stable dosages with limited side effects and low risk of abuse. So the critical question there is are there phenotypic or endo-genotypic characteristics that we can associate with better or worse outcomes that will help us to predict which patients might benefit and so that the cost-benefit ratio will be favorable rather than unfavorable.
Now I’m going to talk about personalized medicine in general and in particular. This refers to this emerging concept approach that uses patient-related factors including the phenotype, that is what information you can observe about the patient and a lot of that information now is contained in the electronic medical record. Also genotypic information that you can gain by collecting a sample and it can be either a sample of blood, or in some cases even a sample of saliva and by going through and looking at snips of DNA and creating biomarkers that select optimum medication and dosage for individual patients. It’s been estimated, on average, that prescription drugs are effective for only about half of those who take them. And for some drugs like anticancer drugs and antidepressants, the so-called non-responder rate is even higher.
Personalized medicine can reduce the non-responder rate because you can focus in on individuals who are highly associated with being respondersand you can eliminate the trial and error inefficiencies that inflate healthcare cost.
An audio recording on Dr. Inturrisi’s full comments can be found here (at the 1:03 mark) and the panel discussion that followed here.
On Friday CMS issued its final decision on beta amyloid imaging. It’s similar to their draft decision in that they ignored the recommendations of the medical community that was calling for full coverage for the Appropriate Use Criteria (AUC) population and imposed Coverage with Evidence Development (CED). CMS will only pay for Alzheimer's imaging tests used in clinical research or to exclude Alzheimer's disease when diagnosing patients in narrow circumstances. There are some slight changes from the initial draft, but from a patient access perspective, we are in the same boat as we were previously, which is non-coverage.
The Alzheimer's Association noted that, in the past, it has taken as long as seven years for CMS to move from a CED designation for new medical technologies to full coverage.
CMS’ move is just the latest example of cost-based thinking trumping patient-centric care
And, as per a recent article in BioCentury, there are significant unintended consequences that will impact the future of personalized medicine.
The cost of demonstrating clinical utility, along with the lack of clear or consistent standards, is killing a business model that had made it possible for small companies to commercialize molecular diagnostics quickly and cheaply. The fate of these laboratory-developed molecular diagnostics companies, and especially the conclusions investors draw about the viability of the space, could shape the future of personalized medicine.
According to research by the Tufts Center for the Study of Drug Development, without clinically useful diagnostics, personalized medicine growth will occur at a relatively slow pace.
And personalized medicine represents the future of healthcare around the world.
Let’s cut to the chase, if we are going to take meaningful strides both in addressing Alzheimer’s Disease specifically and in personalized medicine more broadly, we should not rely on Coverage with Evidence Development (CED) criteria in cases where the FDA’s approval process has expressly evaluated and endorsed the use of a drug or biologic in a specific patient population.
Fact: The evidence on amyloid imaging supports coverage for the population as identified by the Amyloid Imaging Task Force through Appropriate Use Criteria (AUC). A task force, convened by the Alzheimer’s Association and the Society of Nuclear Medicine and Molecular Imaging, recommends coverage in this population based on a comprehensive review of the literature and expert consensus.
Fact: CMS currently covers similar PET technologies to aid in the diagnosis of Alzheimer’s Disease and other forms of cognitive decline. The agency has not previously required evidence of health outcome improvement as a condition of such coverage.
Fact: Using CED alone will deny Medicare beneficiaries adequate and rapid access to this technology, as the path to implementation is unclear. Such uncertainty in the reimbursement process strongly dis-incentivizes future investments in research and development. And without innovation there will not be advances in personalized medicine.
Wither “sustainable innovation?”
Why even bother with expedited review and similar FDA pathways? Clearly closer FDA/CMS coordination is required to address both the will of Congress – and the future of American healthcare.
In the absence of either an FY 2014 appropriation or a Continuing Resolution for FDA, beginning on October 1 and continuing until the date of enactment of an FY 2014 appropriation or Continuing Resolution ("lapse period"), agency operations will be limited to the following:
- Emergency work involving the safety of human life or the protection of property;
- Criminal law enforcement work; and
- Activities funded by carryover user fee balances, including user fee balances under the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Amendments (GDUFA), Medical Device User Fee Amendments (MDUFA), Animal Drug User Fee Act (ADUFA), Animal Generic Drug User Fee Act (AGDUFA), and Family Smoking Prevention and Tobacco Control Act. Carryover user fee balances will only be spent on activities for which the fees are authorized under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
With respect to medical product user fees, during the lapse period, FDA will not have legal authority to accept user fees assessed for FY 2014 until an FY 2014 appropriation for FDA is enacted. This will mean that FDA will not be able to accept any regulatory submissions for FY 2014 that require a fee payment and that are submitted during the lapse period.
If you’re following the multifaceted and global debate over biosimilars, Steve Usdin’s article, Biosimilar battlefronts, is a must read. Authored by BioCentury's Steve Usdin, it’s opening paragraphs set the tone,
Biosimilars developers, manufacturers of originator biologics, payers and consumer groups are battling in state capitals, at FDA headquarters, and at the World Health Organization in Geneva over the rules that will shape perceptions and prescribing practices for copycat biologics in the U.S. and around the world.
Separately, none of the conflicts will have a decisive effect on either biosimilars developers or manufacturers of the products they hope to replace. But collectively, state laws on interchangeable biosimilar substitution, national and international naming practices, and FDA's labeling policies could have powerful effects on the market penetration of biosimilars.
The article covers many issues, both foreign and domestic – and one of the most important and most contentious is the issue of the nonproprietary names assigned to biosimilar and interchangeable biologics.
Usdin writes,
Proponents of distinctive non-proprietary names, including some of the biggest biotech companies, say patient safety and possibly the viability of whole classes of biologic drugs would be threatened by a failure to adopt their recommendations.
However, European regulators say distinct non-proprietary names are unnecessary, and some biosimilars companies argue such a naming scheme would put a dark cloud over biosimilar products that would substantially reduce sales.
A WHO group will meet on Oct. 22 to debate biosimilars naming principles.
The basic disagreement: one camp is arguing for biosimilars to keep the same international non-proprietary name (INN) as the reference product; a second camp argues for distinct INNs.
Supporters of distinct INNs say the ability of regulators to track and trace biologic drugs is essential for patient safety and the commercial viability of biologics — original and biosimilar. Opponents of distinct INNs say they are intended to confuse and scare physicians, patients and payers by drawing unnecessary distinctions between original biologics and biosimilars.
According to Geoffrey Eich, executive director of R&D policy at Amgen, “It seems counterintuitive, like sticking your head in the sand, to not want to include a distinguishing feature that allows us to aggregate info when appropriate and disaggregate when appropriate.”
Amgen supports the use of the reference product’s root INN, with the addition of a unique suffix or prefix for each biosimilar. “We believe having some kind of a distinguishable feature is absolutely essential to patient welfare, for pharmacovigilance,” Amgen’s Eich told BioCentury.
A WHO working group will meet Oct. 22-24 to discuss the creation of voluntary international standards for non-proprietary names for biosimilars.
WHO isn’t likely to adopt a final naming policy at the October meeting. Whatever policy it eventually adopts will not be binding, but it is likely to be adopted by developing countries, and, if it includes a distinctive naming system, could intensify pressure on European countries to adopt new naming policies.
Without casting any aspersions, “quality” and “pharmacovigilance” in developing countries takes on an entirely different meaning than similar concepts in more developed regulatory regimes.
At a meeting in Pretoria last week Tomas Salmonson, Chair of the EMA’s Committee for Medicinal Products for Human Use (CHMP), said that the working group is “split down the middle” on the issue of naming.
Stay tuned.
We do what we must, and call it by the best names. -- Ralph Waldo Emerson
BioCentury This Week is must see TV – especially if you work in the FDA’s government affairs office.
On this weekend’s program Representative Dr. Mike Burgess (R, TX) said that the OMB misinterpreted the law – and that user fees shouldn't have been sequestered.
Dr. Burgess’ comments can be found here.
Dr. Charles Inturrisi is Professor of Pharmacology at Weill Cornell Medical College. He also has appointments in the Neuroscience Program at WCMC and with the Pain and Palliative Care Service, of the Memorial Sloan-Kettering Cancer Center and with the Drug Abuse Center at The Rockefeller University.
Dr. Inturrisi's current research is measuring the long term outcomes of treatments for chronic cancer and noncancer pain received by patients at four hospital-based outpatient Pain Clinics. He continues to have an interest the role of glutamate receptors in injury-induced pain and opioid tolerance, dependence and addictive behaviors. His research is directed at the discovery of new treatments for pain and drug addiction.
Dr. Inturrisi has received the John J. Bonica award of the Eastern Pain Association, a Distinguished Alumnus award from the University of Connecticut and the Excellence in Mentoring Award, Weill Cornell Medical College Postdoctoral Association. In 2008, Dr. Inturrisi received the first Graduate Dean’s Award for Excellence in Teaching and Mentoring of Graduate Students, presented by the Weill Cornell Graduate School of Medical Sciences.
He served as the president of the American Pain Society from 2008 to 2010 and in 2013 received the Distinguished Service Award from APS.
He was a member of the Institute of Medicine Committee that prepared the 2011 Report entitled “Relieving Pain in America”.
You can listen to Dr. Inturrisi’s presentation here (at the 1:03 mark) and the panel discussion that followed here.
Judy Foreman is a nationally syndicated health columnist whose “Health Sense” columns have appeared regularly in the Boston Globe, Los Angeles Times, Dallas Morning News and other national and international outlets. For years, she also wrote the Globe’s popular short feature, “Health Answers.”
She graduated Phi Beta Kappa from Wellesley College, served in the Peace Corps in Brazil for three years, then got a Master’s degree from the Harvard Graduate School of Education. From 2001 to 2004, she was a Lecturer on Medicine at Harvard Medical School and, for most of this time, was a scholar at the Brandeis Women’s Research Center. She has also been the host of a weekly, call-in radio show on Healthtalk.com and has won more than 50 journalism awards.
Her book on chronic pain, “A Nation in Pain – Healing Our Biggest Health Problem,” is due out in January, 2014 from Oxford University Press.
Steve Usdin has been Washington Editor of BioCentury since 1993, and has spent the past 20 years in the nation's capital covering political and policy issues affecting the life sciences sector. He also is the host of BioCentury This Week, BioCentury's weekly public affairs television program, as well as BioCentury Senior Editor responsible for coverage of social issues involving biotechnology. Steve’s reporting about biotechnology and biomedical policy has been cited in The Economist, The Wall Street Journal, the Washington Post, New Scientist and other publications. In 2012, the FDA Alumni Association named Steve the Harvey W. Wiley Lecturer, making him the first journalist to receive the Wiley Award. His book, “Engineering Communism: How Two Americans Spied for Stalin and Founded the Soviet Silicon Valley,” was published in 2005 by Yale University Press.
You can listen to Judy Foreman’s presentation and the panel discussion moderated by Peter Pitts here.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
